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Can Peripheral NIRS Predict the Response to a Fluid Challenge in Pediatric Patients: An Interventional Study

Can Peripheral NIRS Predict the Response to a Fluid Challenge in Pediatric Patients: An Interventional Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05111132
Enrollment
30
Registered
2021-11-08
Start date
2021-10-29
Completion date
2023-09-30
Last updated
2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief summary

This study will be conducted on pediatric patients up to 14 years of age. The effect of two fluid challenge regimes on cerebral and peripheral NIRS will be assessed, in a randomized double blinded controlled trial. The findings will be correlated with two ultrasound measures, previously validated as markers of fluid responsiveness.

Detailed description

The patients will be recruited during the preoperative consultation. After inhalational induction and placement of all monitors, an intravenous access is established. After induction and securing of the airway via endotracheal tube or laryngeal mask, we note the reference values of all parameters. A pre-fluid challenge ultrasound is done, to assess the inferior vena cava distensibillity index, and the Vmax aortic peak flow velocity. After this the fluid challenge is performed. The second ultrasound measures are done after the fluid challenge. Finally an ultrasound is performed at the end of the operation, before emergence, to assess wether the standard peroperative fluid therapy has affecter these measures. NIBP, SpO2, HR, RR, NIRS values will be noted throughout the whole perioperative period. THe end-goald is to correlate the ultrasound findings to the NIRS-values, and see wether the NIRS can be used as a monitor of fluid therapy in pediatric patients.

Interventions

DIAGNOSTIC_TESTFluid challenge (cristalloïd, NaCl 0,9%)

A fluid challenge according to group will be administrated by infusion pump

Sponsors

Erasme University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Years to 14 Years
Healthy volunteers
Yes

Inclusion criteria

* all operations excepting cardiac surgery * BMI \< 30 * ages 1-14 years

Exclusion criteria

* any cardiac affection (congenital unoperated heart disease, arrythmias) * icterus * refusal

Design outcomes

Primary

MeasureTime frameDescription
Effect of fluid challenge on quadricipital NIRS6 hoursWe will assess the effect of fluid challenge on muscular quadricipital in correlation with validated parameters for fluid therapy (dynamic parameters measured by ultrasound: IVC distensibility indec, Vmax aorta)
Effect of fluid challenge on deltoid NIRS6 hoursWe will assess the effect of fluid challenge on muscular deltoid NIRS in correlation with validated parameters for fluid therapy (dynamic parameters measured by ultrasound: IVC distensibility indec, Vmax aorta)
Effect of fluid challenge on cerebbral NIRS6 hoursWe will assess the effect of fluid challenge on cerebral NIRS in correlation with validated parameters for fluid therapy (dynamic parameters measured by ultrasound: IVC distensibility indec, Vmax aorta)

Countries

Belgium

Contacts

Primary ContactPierre Pandin, MD
Pierre.Pandin@erasme.ulb.ac.be+3225555812

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026